The Symbionic Leg is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. The prosthesis is
FDA device recall Z-0936-2014 · posted 2014-02-06 · Terminated
Recall details
- Recalling firm
- Ossur Americas, Inc.
- Reason for recall
- OSSUR initiated this recall of the Symbionic Leg because it may have a possible defect in a small batch of electronics.
- Action taken
- OSSUR contacted all affected customers via phone on February 12, 2013, informing them that a voluntary recall for this product has been implemented, along with the recommended instructions to return the product. A new replacement prosthetic will be provided to the customer. OSSUR has inspected and made appropriate modification to all inventory. ssur will also further strengthen the design and our manufacturing process to ensure an even more robust product. For further questions please call (949) 303-3239.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- ISH
- Quantity affected
- 17 units
- Distribution
- US Distribution including the states of AL, DC, GA, NY, NJ, OK and PA.
- Date initiated
- 2012-02-12
- Date posted
- 2014-02-06
- Date terminated
- 2014-02-06
- Location
- Foothill Ranch, CA
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